- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03805009
Efficacy of End-Effector Robot-Assisted Gait Training in Subacute Stroke Patients
Efficacy of End-Effector Robot-Assisted Gait Training in Subacute Stroke Patients: Clinical and Gait Outcomes
To date, no studies seems to compare conventional gait rehabilitation program with end-effector RAGT in subacute stroke patients by analysing the variations of gait kinematics beyond clinical multi prospective outcomes.
The aim of this pilot study is to evaluate the efficacy of end-effector RAGT in subacute stroke patients in terms of clinical outcomes and gait kinematics, comparing them with conventional gait rehabilitation program.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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RM
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Rome, RM, Italy, 00163
- IRCCS San Raffaele Pisana
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Rome, RM, Italy, 00166
- Fondazione Don Carlo Gnocchi Onlus
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- first cerebral stroke
- 2 weeks up to 6 months post the acute event (subacute patients)
- age between 18-80 years
- ability to fit into the end-effector footplates
- no significant limitation of joint range of motion
- ability to tolerate upright standing for 60 seconds
- ability to walk unassisted or with little assistance
- ability to give written consent
- compliance with the study procedures
Exclusion Criteria:
- contractures of the hip, knee, or ankle joints that might limit the range of motion during gait
- medical issue that precludes full weight bearing and ambulation (e.g. orthopaedic injuries, pain, severe osteoporosis, or severe spasticity)
- cognitive and/or communicative disability (e.g. due to brain injury): inability to understand the instructions required for the study
- cardiac pathologies, anxiety or psychosis that might interfere with the use of the equipment or testing
Written informed consent was obtained from each subject.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Robotic Group (RG)
Robotic Group (RG) will perform, in addition to conventional therapy, gait training using an end-effector robotic device for Robot-Assisted Gait Training (RAGT), 3 times/week for 20 sessions.
During the training, patients will be asked to walk, at a varying speed, for 45 minutes and a partial Body Weight Support (BWS).
Participants will start with 30-40% of BWS and an initial speed of 1.5 km/h; increasing to a maximum of between 2.2 and 2.5 km/h and reducing the initial BWS to 15%.
The therapist will provide any help during sessions if required.
Over 45 minutes, the patient simulates a minimum of 300 steps; patients could rest during the session, though they will be asked to walk continuously for a minimum of 5 minutes during each session.
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The Robotic Group (RG) performs a Robot-Assisted Gait Training (RAGT) using an end-effector robotic device (G-EO system-Reha Technology-Olten, Switzerland).
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No Intervention: Conventional Group (CG)
Conventional Group (CG) will perform conventional gait rehabilitation program.
The treatment will include: muscle strengthening exercises and stretching of the lower limb, and static and dynamic exercises for the recovery of balance in the supine and standing positions using assistive devices; training gait exercises with parallel bars or in open spaces performed both with and without assistive devices; training to climb up and down stairs; exercises to improve proprioception in the supine, sitting and standing positions, using a proprioceptive footboard; exercises to improve trunk control.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Six-Minute Walking Test (6MWT)
Time Frame: Session 1 (baseline), and Session 20 (week 7)
|
The 6MWT measures the distance a subject covers during an indoor gait on a flat, hard surface in 6 minutes, using assistive devices, as necessary.
The test is a reliable and valid evaluation of functional exercise capacity and is used as a sub-maximal test of aerobic capacity and endurance.
The minimal detectable change in distance for people with sub-acute stroke is 60.98 meters.
The 6MWT is a patient self-paced walk test and assesses the level of functional capacity.
Patients are allowed to stop and rest during the test.
However, the timer does not stop.
If the patient is unable to complete the test, the time is stopped at that moment.
The missing time and the reason of the stop are recorded.
This test will be administered while wearing a pulse oximeter to monitor heart rate and oxygen saturation, also integrated with Borg scale to assess dyspnea.
|
Session 1 (baseline), and Session 20 (week 7)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Fugl-Meyer Assessment (FMA) scale
Time Frame: Session 1 (baseline), and Session 20 (week 7)
|
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment. The scale is comprised of five domains and there are 155 items in total:
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Session 1 (baseline), and Session 20 (week 7)
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Change in Motricity Index (MI)
Time Frame: Session 1 (baseline), and Session 20 (week 7)
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The MI aims to evaluate lower limb motor impairment after stroke, administrated on both sides. Items to assess the lower limbs are 3, scoring from 0 to 33 each: (1) ankle dorsiflexion with foot in a plantar flexed position (2) knee extension with the foot unsupported and the knee at 90° (3) hip flexion with the hip at 90° moving the knee as close as possible to the chin. (no movement: 0, palpable flicker but no movement: 9, movement but not against gravity :14, movement against gravity movement against gravity: 19, movement against resistance: 25, normal:33) |
Session 1 (baseline), and Session 20 (week 7)
|
Change in Modified Ashworth Scale (MAS)
Time Frame: Session 1 (baseline), and Session 20 (week 7)
|
The MAS is a 6 point ordinal scale used for grading hypertonia in individuals with neurological diagnoses.
A score of 0 on the scale indicates no increase in tone while a score of 4 indicates rigidity.
Tone is scored by passively moving the individual's limb and assessing the amount of resistance to movement felt by the examiner.
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Session 1 (baseline), and Session 20 (week 7)
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Change in Tinetti Scale Balance (TIN-B)
Time Frame: Session 1 (baseline), and Session 20 (week 7)
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Scales to measure activity ICF domain.
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Session 1 (baseline), and Session 20 (week 7)
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Change in Tinetti Walking (TIN-W)
Time Frame: Session 1 (baseline), and Session 20 (week 7)
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Scales to measure activity ICF domain.
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Session 1 (baseline), and Session 20 (week 7)
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Change in Functional Ambulation Classification (FAC)
Time Frame: Session 1 (baseline), and Session 20 (week 7)
|
Functional Ambulation Classification is a functional walking test that evaluates ambulation ability.
This 6-point scale assesses ambulation status by determining how much human support the patient requires when walking, regardless of whether or not they use a personal assistive device.
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Session 1 (baseline), and Session 20 (week 7)
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Change in Trunk Control Test (TCT)
Time Frame: Session 1 (baseline), and Session 20 (week 7)
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The TCT assesses the motor impairment in stroke patients and it's correlated with eventual walking ability.
Testing is done with the patient lying on a bed: (1) roll to weak side.
(2) roll to strong side.
(3) balance in sitting position on the edge of the bed with the feet off the ground for at least 30.
(4) sit up from lying down.
Total score: 0-100
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Session 1 (baseline), and Session 20 (week 7)
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Change in 10 Meter Walk Test (10MWT)
Time Frame: Session 1 (baseline), and Session 20 (week 7)
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This test will assess the patient's speed during gait.
Patients will be asked to walk at their preferred maximum and safe speed.
Patients will be positioned 1 meter before the start line and instructed to walk 10 meters, and pass the end line approximately 1 meter after.
The distance before and after the course are meant to minimize the effect of acceleration and deceleration.
Time will be measured using a stopwatch and recorded to the one hundredth of a second (ex: 2.15 s).
The test will be recorded 3 times, with adequate rests between them.
The average of the 3 times should be recorded.
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Session 1 (baseline), and Session 20 (week 7)
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Change in Time Up And Go (TUG)
Time Frame: Session 1 (baseline), and Session 20 (week 7)
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The Time Up And Go is a test used to assess mobility, balance, and walking in people with balance impairments.
The subject must stand up from a chair (which should not be leant against a wall), walk a distance of 3 meters, turn around, walk back to the chair and sit down - all performed as quickly and as safely as possible.
Time will be measured using a chronometer.
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Session 1 (baseline), and Session 20 (week 7)
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Change in Walking Handicap Scale (WHS)
Time Frame: Session 1 (baseline), and Session 20 (week 7)
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The Walking Handicap Scale is a classification of 6 functional walking categories, considered as a participation category of the ICF because of its 3 items referred to community ambulation.
The score ranges from 1 to 6, and do higher values represent a better outcome.
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Session 1 (baseline), and Session 20 (week 7)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gait Analysis
Time Frame: Session 1 (baseline), and Session 20 (week 7)
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Kinematic and kinetic gait parameters will be calculated from data acquired with a motion capture system (SMART-DX; BTSBioengneering, Italy).
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Session 1 (baseline), and Session 20 (week 7)
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Postural Analysis
Time Frame: Session 1 (baseline), and Session 20 (week 7)
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Posturographic parameters will be obtained from the analysis of the center of pressure (COP) trajectories measured by force platforms during standing in both open and closed eyes conditions.
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Session 1 (baseline), and Session 20 (week 7)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Marco Franceschini, MD, IRCCS San Raffaele Pisana
- Principal Investigator: Sanaz Pournajaf, Dr, IRCCS San Raffaele Pisana
- Principal Investigator: Michela Goffredo, Ing, IRCCS San Raffaele Pisana
Publications and helpful links
General Publications
- Palmieri L, Barchielli A, Cesana G, de Campora E, Goldoni CA, Spolaore P, Uguccioni M, Vancheri F, Vanuzzo D, Ciccarelli P, Giampaoli S; Research Group of the Project 'Italian National Register of Coronary and Cerebrovascular Events'. The Italian register of cardiovascular diseases: attack rates and case fatality for cerebrovascular events. Cerebrovasc Dis. 2007;24(6):530-9. doi: 10.1159/000110423. Epub 2007 Oct 29.
- Swinnen E, Beckwee D, Meeusen R, Baeyens JP, Kerckhofs E. Does robot-assisted gait rehabilitation improve balance in stroke patients? A systematic review. Top Stroke Rehabil. 2014 Mar-Apr;21(2):87-100. doi: 10.1310/tsr2102-87.
- Eng JJ, Tang PF. Gait training strategies to optimize walking ability in people with stroke: a synthesis of the evidence. Expert Rev Neurother. 2007 Oct;7(10):1417-36. doi: 10.1586/14737175.7.10.1417.
- Langhorne P, Coupar F, Pollock A. Motor recovery after stroke: a systematic review. Lancet Neurol. 2009 Aug;8(8):741-54. doi: 10.1016/S1474-4422(09)70150-4.
- Mehrholz J, Thomas S, Werner C, Kugler J, Pohl M, Elsner B. Electromechanical-assisted training for walking after stroke. Cochrane Database Syst Rev. 2017 May 10;5(5):CD006185. doi: 10.1002/14651858.CD006185.pub4.
- Pons, J. L. (2008). Wearable robots: biomechatronic exoskeletons. John Wiley & Sons. 127-164.
- Hesse S, Waldner A, Tomelleri C. Innovative gait robot for the repetitive practice of floor walking and stair climbing up and down in stroke patients. J Neuroeng Rehabil. 2010 Jun 28;7:30. doi: 10.1186/1743-0003-7-30.
- Mehrholz J, Pohl M. Electromechanical-assisted gait training after stroke: a systematic review comparing end-effector and exoskeleton devices. J Rehabil Med. 2012 Mar;44(3):193-9. doi: 10.2340/16501977-0943.
- Kelley CP, Childress J, Boake C, Noser EA. Over-ground and robotic-assisted locomotor training in adults with chronic stroke: a blinded randomized clinical trial. Disabil Rehabil Assist Technol. 2013 Mar;8(2):161-8. doi: 10.3109/17483107.2012.714052. Epub 2012 Sep 20.
- Cho DY, Park SW, Lee MJ, Park DS, Kim EJ. Effects of robot-assisted gait training on the balance and gait of chronic stroke patients: focus on dependent ambulators. J Phys Ther Sci. 2015 Oct;27(10):3053-7. doi: 10.1589/jpts.27.3053. Epub 2015 Oct 30.
- Li L, Ding L, Chen N, Mao Y, Huang D, Li L. Improved walking ability with wearable robot-assisted training in patients suffering chronic stroke. Biomed Mater Eng. 2015;26 Suppl 1:S329-40. doi: 10.3233/BME-151320.
- Bonnyaud C, Pradon D, Boudarham J, Robertson J, Vuillerme N, Roche N. Effects of gait training using a robotic constraint (Lokomat(R)) on gait kinematics and kinetics in chronic stroke patients. J Rehabil Med. 2014 Feb;46(2):132-8. doi: 10.2340/16501977-1248.
- Lonini L, Shawen N, Scanlan K, Rymer WZ, Kording KP, Jayaraman A. Accelerometry-enabled measurement of walking performance with a robotic exoskeleton: a pilot study. J Neuroeng Rehabil. 2016 Mar 31;13:35. doi: 10.1186/s12984-016-0142-9.
- Gandolfi M, Geroin C, Picelli A, Munari D, Waldner A, Tamburin S, Marchioretto F, Smania N. Robot-assisted vs. sensory integration training in treating gait and balance dysfunctions in patients with multiple sclerosis: a randomized controlled trial. Front Hum Neurosci. 2014 May 22;8:318. doi: 10.3389/fnhum.2014.00318. eCollection 2014.
- Sale P, Russo EF, Russo M, Masiero S, Piccione F, Calabro RS, Filoni S. Effects on mobility training and de-adaptations in subjects with Spinal Cord Injury due to a Wearable Robot: a preliminary report. BMC Neurol. 2016 Jan 28;16:12. doi: 10.1186/s12883-016-0536-0.
- Dundar U, Toktas H, Solak O, Ulasli AM, Eroglu S. A comparative study of conventional physiotherapy versus robotic training combined with physiotherapy in patients with stroke. Top Stroke Rehabil. 2014 Nov-Dec;21(6):453-61. doi: 10.1310/tsr2106-453.
- Hornby TG, Campbell DD, Kahn JH, Demott T, Moore JL, Roth HR. Enhanced gait-related improvements after therapist- versus robotic-assisted locomotor training in subjects with chronic stroke: a randomized controlled study. Stroke. 2008 Jun;39(6):1786-92. doi: 10.1161/STROKEAHA.107.504779. Epub 2008 May 8. Erratum In: Stroke.2008 Aug;39(8): e143.
- Aprile I, Iacovelli C, Padua L, Galafate D, Criscuolo S, Gabbani D, Cruciani A, Germanotta M, Di Sipio E, De Pisi F, Franceschini M. Efficacy of Robotic-Assisted Gait Training in chronic stroke patients: Preliminary results of an Italian bi-centre study. NeuroRehabilitation. 2017;41(4):775-782. doi: 10.3233/NRE-172156.
- Taveggia G, Borboni A, Mule C, Villafane JH, Negrini S. Conflicting results of robot-assisted versus usual gait training during postacute rehabilitation of stroke patients: a randomized clinical trial. Int J Rehabil Res. 2016 Mar;39(1):29-35. doi: 10.1097/MRR.0000000000000137.
- Mao YR, Lo WL, Lin Q, Li L, Xiao X, Raghavan P, Huang DF. The Effect of Body Weight Support Treadmill Training on Gait Recovery, Proximal Lower Limb Motor Pattern, and Balance in Patients with Subacute Stroke. Biomed Res Int. 2015;2015:175719. doi: 10.1155/2015/175719. Epub 2015 Nov 16.
- Davis RB, Ounpuu S, Tyburski D, Gage JR. A gait analysis data collection and reduction technique. Hum MovSci 1991; 10: 575-587.
- Winter DA. Biomechanics and motor control of human movement. John Wiley & Sons, 2009.
- Nichols-Larsen DS, Clark PC, Zeringue A, Greenspan A, Blanton S. Factors influencing stroke survivors' quality of life during subacute recovery. Stroke. 2005 Jul;36(7):1480-4. doi: 10.1161/01.STR.0000170706.13595.4f. Epub 2005 Jun 9.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RP 15/13
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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